378 Ctd Jobs - Page 12

About The Role : Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecy...

Template Job Title M&E Registrations Associate Manager - Meetings and Events Management Level:CL8 Location:Gurugram Must have skills:Cvent Event Management suite of products Good to have skills:HTML, CSS Job Summary : We are seeking a seasoned leader who is organized, detail-oriented, and a proactive registration website builder to independently manage and support multiple events simultaneously. This role involves providing exceptional customer service, leading a global website builder team, coordinating team meetings, and ensuring smooth running of Meetings and Events operations. The ideal candidate will possess strong communication skills, a passion for event coordination, and the ability ...

Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more ...

IVL India Environmental RD is looking for Quality Expert to join our dynamic team and embark on a rewarding career journey. Develop and implement quality assurance policies and procedures. Conduct quality audits and inspections. Analyze data to identify areas for improvement. Provide training on quality standards and processes. Ensure compliance with regulatory requirements.

Wte Infra Projects Pvt Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new p...

Key Responsibilities will include : 1) Experience in technical review and compilation of registration dossiers for regulated markets. 2) Review of master documents (Specifications, MFR, BMR, BPR, PVP, PVR, HTSP, HTSR, PDR, elemental impurity risk assessment, nitrosamine risk assessment, stability protocols), DMF. 3) Deficiency management for products filed to regulated markets.

Knowledge on Regulatory guidelines for API & Finished product registration. Preparation, Review and submission of Technical documents/Dossiers (CTD/ACTD) for Regulatory and Non Regulatory Markets. Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling of customer and MOH queries. Coordination with cross-functional teams & Reviewing of Documents (Specification, MOA, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Should have hand on experience in handling OD...

Kamla Homes is looking for Officer- RA to join our dynamic team and embark on a rewarding career journey Prepare regulatory submissions for product approvals Ensure compliance with domestic and global regulations Monitor regulatory changes and update dossiers Coordinate with QA and production for alignment

Apollo Pipes Ltd is looking for Area Sales Manager to join our dynamic team and embark on a rewarding career journey. Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands companys customer base and ensure it s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully aware of new products an...

Preparation & review of US ANDAs/ 505(b)(2)/EU/ Canada dossiers for Parenteral products as per regulatory requirements. Preparation & review of deficiency responses, regulatory strategy note, controlled correspondences, Briefing books, labeling, artworks and ScA meeting packages. Coordinate with internal stake holders (R&D, AR&D, SCM, FTO, CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs. Identify all open issues at product development, ANDA filing and deficiency responses in consultation with team lead/RA vertical head. Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for com...

Elevate Your Career with us, we're Seeking Masterminds to Drive Excellence! Evolet Healthcare Pvt. Ltd. is hiring for the position of Sr./Executive- Drugs Regulatory Affairs. Job Description: Having experience in dossier compilation (CTD & ACTD) for CIS, ASEAN, LATAM and AFRICAN countries. Controlling the whole process of registration products from the beginning till the end. Evaluation of Bioequivalence and Clinical Trials (preferably). Required Candidate profile: Having knowledge of ICH guideline with relevant 1-5 years of experience. Having experience in registration any CIS, ASEAN, LATAM and AFRICAN countries. To be flexible for travelling and meeting with manufacturing plant representat...

Providing insights on industry and market developments, including policy and regulatory updates to advocate for favourable outcomes. Analysis of Regulations, Guidelines, Policies, Important order, etc. to derive meaningful insights & actionable for higher management. Support in Policy Advocacy, legal & regulatory on filing petitions with appropriate authority. Support in review of bidding, bid documents, RFS & PPA. Support in creation of Memorandums of Understanding (MOU) with government bodies, ensuring alignment with legal and strategic frameworks. Supporting business development and project expansion, ensuring alignment with ENGIEs strategy and objectives. Building positive relationships ...

As a global leader in cybersecurity, CrowdStrike protects the people, processes and technologies that drive modern organizations Since 2011, our mission hasnt changed "” were here to stop breaches, and weve redefined modern security with the worlds most advanced AI-native platform Our customers span all industries, and they count on CrowdStrike to keep their businesses running, their communities safe and their lives moving forward Were also a mission-driven company We cultivate a culture that gives every CrowdStriker both the flexibility and autonomy to own their careers Were always looking to add talented CrowdStrikers to the team who have limitless passion, a relentless focus on innovation...

Guide the upgrade and development of plant infrastructure and systems to meet the requirements of: WHO-GMP, Russia, Australia/New Zealand, and African regulatory authorities, Ultimately UKMHRA and USFDA. Provide expert support on: WHO-GMP and GLP.

About The Role What you will do Let’s do this. Let’s change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by: Driving continuous improvement of processes and tools Ensuring awareness of processes across the organization; and Shaping the training strategy across the organization The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes. Job responsibilities of the SPPM Man...

We are looking for a highly motivated and experienced Business Development Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 3 to 8 years of experience in the BFSI industry, preferably in used car finance. Roles and Responsibility Develop and implement effective business strategies to achieve sales targets. Build and maintain strong relationships with clients and stakeholders. Conduct market research and analyze competitor activity to stay ahead in the market. Collaborate with cross-functional teams to drive business growth. Identify and mitigate risks associated with business development activities. Monitor and report on business performance metrics. ...

We are looking for a skilled AML & KYC Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-6 years of experience in the BFSI industry, with expertise in Anti Money Laundering and Know Your Customer. Roles and Responsibility Develop and implement effective AML/KYC policies and procedures to prevent financial crimes. Conduct thorough risk assessments to identify potential threats and vulnerabilities. Collaborate with internal stakeholders to ensure compliance with regulatory requirements. Monitor and analyze transactional data to detect suspicious activity. Provide training and guidance to staff on AML/KYC best practices. Maintain accurate records and re...

We are looking for a highly motivated and experienced Branch Operations Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2 to 7 years of experience in the BFSI industry. Roles and Responsibility Manage daily branch operations, ensuring efficient workflow and customer satisfaction. Supervise and coordinate with branch staff to achieve operational goals. Develop and implement strategies to improve branch performance and productivity. Maintain high standards of customer service, resolving complaints and queries promptly. Ensure compliance with regulatory requirements and internal policies. Analyze operational data to identify areas for improvement and op...

We are looking for a highly skilled and experienced Technical Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-4 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee technical aspects of projects, ensuring timely completion and quality delivery. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and implement technical solutions to meet business needs. Conduct thorough analysis of technical issues and provide effective resolutions. Ensure compliance with industry standards and regulatory requirements. Provide technical guidance and support to junior team members. Job Requ...

We are looking for a skilled AML & KYC Analyst to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 3-10 years of experience in the BFSI industry, with expertise in Anti Money Laundering and Know Your Customer regulations. Roles and Responsibility Conduct thorough risk assessments to identify potential anti-money laundering threats. Develop and implement effective mitigation strategies to prevent financial crimes. Collaborate with internal stakeholders to ensure compliance with regulatory requirements. Perform regular audits to detect suspicious transactions and report findings. Maintain accurate records of all interactions with customers and transactions. Stay u...

Dossier preparation as per CTD/ACTD/eCTD/Regional guidelines. To co-ordinate with plant team i.e. QA, QC, Production department for availability of technical & legal documents in the given time-line. Review of documents received from plant team and co-ordinate with respective departments in case of any discrepancies. Review of dossiers prepared by team-mates. To ensure that the registration samples be available as per pre-defined time-frame. Submission of response to Queries / Deficiencies raised by Customers / Regulatory Authorities within timeline. Artworks review & approval Co-ordination with Clients / Customers for the registration updates, plant approval process etc. To maintain & updat...

Job Area: Finance & Accounting Group, Finance & Accounting Group > Global Accounting Ops Center General Summary: Company: Job Overview: As a Project Manager, you will play a key role in coordinating with partners and stakeholders to ensure the successful delivery of critical business projects. Project Managers will navigate barriers and work closely with functional team members to guide each project to completion. This role requires cross-functional collaboration and impeccable organization skills to deliver projects in a timely manner and within budget. Minimum Qualifications: Bachelor's degree 5+ years of Project Management-relevant work experience in Finance 2+ years of managing operating...

• Develop and review content for various regulatory documents; ensure quality as per setegulatory standards and compliance requirement. • Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format. • Candidate will need to author and/or review clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD for submission to the Health Authorities in EU and APAC markets, respectively. Key requirement: • Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development and review of clinical and non-clinical documents under Module 2, 4 and 5 of eC...

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge o...

Desired Experience : 3-7 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Deputy Manager/ Assistant Manager/ Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Main purpose of the Job: Responsible for Preparation of Regulatory Documents for submission to Indian NRA, WHO and other Regulatory Authorities. Job Responsibilities: 1. Preparation of following Regulatory Submission Packages related to NRA submissions but not limited to. a. Application for Post Approval Change(s) b. Marketing Authorization Applications c. Clinical trial applications d. Support the submission of Import licenses/ export NoC e. Support...